This Biotech Stock Could Double By Year-End 2024
Taking a Look at Relay Therapeutics (RLAY).
I've transitioned to exclusively logging my weekly activity and tracking my portfolio in real-time on Savvy Trader.
For those not yet in the loop, I invite you to join me on this journey. Subscribe using the link below to gain direct insights:
By subscribing, you'll engage directly with me regarding specific companies, access my performance in real-time (with data starting under a year), and get detailed views of my investments, real-time trading actions, cash positions, and more. This move is driven by my commitment to transparency. I believe that sharing my analytical insights and the reasoning behind my investment choices offers immense value, empowering you with the information you need to make informed decisions.
What’s the Big Deal?
Relay Therapeutics (RLAY) is a pre-revenue biopharmaceutical company that leverages a unique combination of experimental biology and computational techniques to develop precision medicines for cancer and genetic diseases. Utilizing their proprietary Dynamo platform, RLAY integrates deep computational insights with extensive laboratory experimentation to identify and optimize novel drug candidates. This approach enables them to target complex and dynamic protein structures, which are often difficult to address with traditional drug discovery methods. So, basically, this company is using artificial intelligence for drug discovery and development.
RLAY's pipeline includes multiple clinical and preclinical programs focused on key cancer drivers and genetic mutations, such as PI3Kα in breast cancer and other solid tumors, as well as innovative therapies for genetic disorders like Fabry disease. The company's mission is to transform the treatment landscape by delivering highly effective, targeted therapies that address significant unmet medical needs.
For more detailed information on what Relay Therapeutics does, please reference my archive.
In June 2024, the company released a corporate presentation, which gave more color on their operations, future, and pipeline. The hidden gem of this company, and the primary focus of our attention, is their RLY-2608 product. This promising drug targets breast cancer, specifically the PI3Kα gene (which is actually present in many different cancers, making this a versatile product), which serves as the major catalyst for future capital appreciation. Based on their recent presentation, here’s what we know about RLY-2608:
Dose Escalation and Expansion:
RLY-2608 has been tested in dose escalation phases with 400mg and 600mg BID (twice daily) doses. The expansion cohorts continue to enroll patients, particularly in combination with fulvestrant and CDK4/6 inhibitors.
Efficacy Data:
Early data indicate promising efficacy, especially in heavily pre-treated patients. For the 600mg BID dose combined with fulvestrant, the clinical benefit rate (CBR) has been notably high at 86% among patients with at least six months of follow-up.
Confirmed partial responses have been observed, indicating significant anti-tumor activity. Specifically, one confirmed partial response out of five efficacy-evaluable patients with measurable disease was reported at the 600mg BID dose level.
Overall, across various doses and combinations, 4 partial responses were observed out of 24 evaluable breast cancer patients.
Safety and Tolerability:
The safety profile of RLY-2608 has been favorable, with a lower incidence of common PI3K inhibitor-related side effects such as hyperglycemia, rash, and diarrhea.
Data from interim analyses as of July 2023 also support the drug's selectivity and limited impact on glucose homeostasis, which is a critical factor in the tolerability of PI3K inhibitors.
Clinical Trials and Future Data:
The ongoing ReDiscover trial is expected to provide more comprehensive efficacy data by the end of 2024. This includes data on progression-free survival (PFS) for the doublet combinations and early safety and tolerability data for the triplet combinations.
Preliminary data from the ReDiscover trial showed that RLY-2608, in combination with fulvestrant, is associated with a high rate of disease control and partial responses in breast cancer patients.
For us Normal Folks, What Does this Mean?
Clinical Trials and Phases
In the dose escalation and expansion phases, different doses of RLY-2608 are being tested to identify the best and safest dose. So far, 400mg and 600mg doses taken twice a day have been evaluated. Additionally, the efficacy of RLY-2608 in combination with other cancer treatments like fulvestrant (a common breast cancer drug) and CDK4/6 inhibitors is being assessed.
Efficacy Data (How Well the Drug Works)
Early results are promising, particularly for patients who have previously undergone multiple treatments. For patients taking the 600mg dose of RLY-2608 with fulvestrant, 86% experienced significant benefits, with their cancer either stopping growth or shrinking for at least six months. Specifically, one out of five patients showed a measurable reduction in tumor size at the 600mg dose, and overall, four out of twenty-four patients demonstrated partial responses, indicating the drug's positive impact.
Safety and Tolerability (How Safe the Drug Is)
RLY-2608 has shown a favorable safety profile compared to other similar drugs, with fewer patients experiencing side effects like high blood sugar, rashes, and diarrhea. This suggests that the drug is not only effective but also better tolerated by patients.
Ongoing Trials and Future Data
The ongoing ReDiscover trial is expected to provide more comprehensive data by the end of 2024, including how long patients remain free from cancer progression and additional safety data. Early indications suggest that RLY-2608 effectively controls cancer while maintaining a relatively safe profile.
In summary, RLY-2608 shows great promise in treating certain types of cancer, particularly in combination with other treatments. Its manageable safety profile and early efficacy results are very encouraging. The next pivotal data readout will be in Q4 of 2024, and if it shows positive results, this could easily double from our prices today.
What’s the importance here? Well, this will open an addressable market that is essentially uncapped if it succeeds. Although it is primarily being developed to target breast cancer, specifically breast cancers that have mutations in the PI3Kα gene, these mutations can drive many different types of cancer growths. The trials and data discussed focus on its use in combination with other treatments for breast cancer, such as fulvestrant and CDK4/6 inhibitors. However, RLY-2608 is also being explored for its potential efficacy in other solid tumors with similar PI3Kα mutations.
The versatility comes from its mechanism of action, which focuses on inhibiting the PI3Kα protein. Mutations in the PI3Kα gene can be found in various types of cancers, not just breast cancer.
RLY-2608 is being studied for its efficacy in other solid tumors with PI3Kα mutations, including:
Endometrial Cancer: Cancer that begins in the lining of the uterus.
Colorectal Cancer: Cancer of the colon or rectum.
Bladder Cancer: Cancer that begins in the bladder.
Prostate Cancer: Cancer that begins in the prostate gland.
Non-Small Cell Lung Cancer (NSCLC): A group of lung cancers that behave similarly.
Head and Neck Squamous Cell Carcinoma (HNSCC): A type of cancer that arises in the mucous membranes of the mouth, nose, and throat.
Clinical Trials and Development
Monotherapy and Combinations: RLY-2608 is being tested both as a standalone treatment (monotherapy) and in combination with other cancer treatments to assess its efficacy across different types of cancers.
Ongoing Research: Trials are ongoing to better understand its effectiveness and safety profile in these various cancer types.
When we look at the data for June 2024, they say that four out of the 24 patients showed partial responses, it means that four patients had their tumors shrink by a measurable amount according to specific criteria used in clinical trials. This does not mean that the other 20 patients didn't benefit at all though.
A partial response (PR) is a specific type of positive outcome where the tumor size decreases by a certain percentage but does not disappear completely. This is a strong indicator that the drug is working. In this case, four patients out of the 24 had their tumors shrink significantly, which is classified as a partial response. The clinical benefit rate (CBR) includes patients who have a partial response, complete response (tumors disappear), or stable disease (tumors do not grow) for a certain period. For the 600mg dose group, the CBR was 86%, meaning that most patients either had their tumors shrink, remain stable, or disappear for at least six months.
Regarding the other 20 patients, some may have experienced stable disease (SD), where the tumors did not shrink significantly but also did not grow, which is still considered a positive outcome because the cancer is not progressing. Some patients might have had progressive disease (PD), meaning their cancer progressed despite the treatment, leading to tumor growth. Additionally, some patients might not have been on the treatment long enough to see a significant effect, or the data was not yet available for them at the time of the report.
So, 4 out of 24 patients had their tumors shrink significantly (PR). The clinical benefit rate (CBR) was 86%, indicating that most patients had some level of benefit, whether the tumors shrank, stayed the same size, or grew very slowly. While only four patients had a measurable reduction in tumor size, many of the other patients still benefited from the treatment by having stable disease or other positive outcomes. The 86% CBR suggests that the majority of patients experienced some form of clinical benefit from the treatment.
This is the significance and potential of the market that RLAY is poised to tap into, which has never been done before (or “Big Deal” if you will). The upcoming readout by the EOY could be a major milestone for the company. As of Q1 2024, RLAY had approximately $750M in cash, sufficient to fund their current operating plan into the second half of 2026. This is one of my favorite biotech plays in this field, along with Coherus BioSciences (CHRS). Before the end of the year, I plan to regularly add to my position to secure a comfortable stake before the results are released. Could this not deliver? Absolutely. But the probability of success is in our favor at the moment.